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PMV Pharmaceuticals Reports Second Quarter 2025 Financial Results and Corporate Highlights
GlobeNewswire News Room· 2025-08-07 12:42
Core Viewpoint - PMV Pharmaceuticals reported its financial results for Q2 2025, highlighting a significant increase in net loss and ongoing clinical trials for its lead product, rezatapopt, which targets p53 mutations in various cancers [3][7]. Financial Results - As of June 30, 2025, PMV Pharma had $148.3 million in cash, cash equivalents, and marketable securities, down from $165.8 million as of March 31, 2025 [3][6]. - The net loss for Q2 2025 was $21.2 million, a substantial increase from $1.2 million in Q2 2024, primarily due to the previous year's tax benefit from the sale of accumulated net operating losses [7]. - Research and development (R&D) expenses rose to $18.4 million in Q2 2025 from $14.6 million in Q2 2024, attributed to increased costs associated with the rezatapopt program [7]. - General and administrative (G&A) expenses decreased to $4.5 million in Q2 2025 from $5.5 million in Q2 2024, mainly due to reduced stock-based compensation and operational costs [7]. Clinical Development - PMV Pharma is advancing the Phase 2 PYNNACLE clinical trial for rezatapopt, with an investor webinar scheduled for September 10, 2025, to present interim analysis data from approximately 65 patients [2][6]. - The PYNNACLE trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with a focus on efficacy and safety [5][6]. Product Information - Rezatapopt (PC14586) is a first-in-class small molecule designed to reactivate the p53 tumor suppressor function in patients with specific mutations [4]. - The U.S. FDA has granted Fast Track designation to rezatapopt for treating locally advanced or metastatic solid tumors with a p53 Y220C mutation [4]. Company Overview - PMV Pharmaceuticals specializes in precision oncology, focusing on small molecule therapies targeting p53 mutations, which are present in approximately half of all cancers [8]. - The company was co-founded by Dr. Arnold Levine, a pioneer in p53 biology, and is headquartered in Princeton, New Jersey [8].
PMV Pharmaceuticals(PMVP) - 2025 Q2 - Quarterly Report
2025-08-07 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39539 PMV PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) Delaware 46-3218129 (State or other jurisdi ...
PMV Pharmaceuticals(PMVP) - 2025 Q2 - Quarterly Results
2025-08-07 12:00
Exhibit 99.1 PMV Pharmaceuticals Reports Second Quarter 2025 Financial Results and Corporate Highlights PRINCETON, N.J., August 7, 2025 (GLOBE NEWSWIRE) - PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today reported financial results for the second quarter ended June 30, 2025, and provided a corporate update. PMV Pharma will host an investor webinar on W ...
PMV Pharmaceuticals (PMVP) Earnings Call Presentation
2025-07-01 06:43
Rezatapopt Clinical Development - PMV Pharma's lead candidate, rezatapopt (PC14586), is a first-in-class p53 Y220C reactivator targeting the previously undruggable p53 Y220C mutation, found in approximately 1% of solid tumors[4,9] - Rezatapopt has shown clinical proof of concept with favorable safety and preliminary efficacy across multiple tumor types[4] - A single-arm, registrational, tumor-agnostic Phase 2 trial was initiated in Q1 2024, with an interim analysis planned for mid-2025 and NDA submission planned for the end of 2026[4] - In the Phase 1 study, tumor shrinkage was observed in 87% of patients with measurable disease at baseline, KRAS wild type, and at least one post-baseline assessment in the efficacious dose range[22] - Confirmed responses at the Recommended Phase 2 Dose (RP2D) of 2000 mg QD showed an Overall Response Rate (ORR) of 38% in TP53 Y220C/KRAS WT patients[24] - The median time to response in the efficacious dose range for TP53 Y220C/KRAS WT patients was 15 months[27] Safety and Tolerability - Rezatapopt demonstrated a favorable safety profile, with most Treatment-Related Adverse Events (TRAEs) being Grade 1 or 2[29] - The most frequent TRAEs were nausea (507%) and vomiting (433%), which improved when rezatapopt was given with food[29] - The rate of drug discontinuation due to a TRAE was low at 3%[29] Financial Position and Future Plans - PMV Pharma had $198 million in cash as of September 30, 2024, providing a cash runway to year-end 2026[4] - The Phase 2 trial includes defined registration paths in ovarian and tumor-agnostic patient populations, with approximately 90% of TP53 Y220C patients being KRAS wild type[39,42]
PMV Pharmaceuticals (PMVP) 2025 Conference Transcript
2025-06-05 20:45
Summary of PMV Pharma Conference Call Company Overview - PMV Pharma was founded approximately eleven years ago by David Mack, Arne Levine, and Thomas Shank, focusing on harnessing the power of the p53 protein [3][4] - The company is currently advancing its Phase two registrational study for rizatapupt, targeting the TP53Y220C mutation in solid tumors [3][4] Current Programs and Clinical Trials - The Phase one program evaluated rizatapupt, leading to a successful transition into Phase two, with enrollment expected to complete by the end of this year [4][36] - An interim analysis is planned for mid-year, sharing data from around 50 patients, including 20 with ovarian cancer [4][36] - The Y220C mutation occurs in approximately 1% of all solid tumors and 3% in ovarian cancer, driving the design of a basket study across multiple tumor types [9][10] Efficacy and Safety Data - Preliminary Phase one data showed a 38% confirmed overall response rate across six tumor types, with a median duration of response (DOR) of seven months [11][35] - Safety profile was favorable, primarily grade one and two treatment-related adverse events, mainly gastrointestinal toxicities, which were mitigated by food [12][35] Study Design and Regulatory Alignment - The FDA provided alignment on the Phase two study design and recommended dose in July 2023, facilitating a potential registration path [22][23] - The Phase two study aims for a 30% response rate in ovarian cancer patients, with a confidence interval lower bound excluding 12% [24][31] Enrollment and Future Plans - Enrollment is on track, with 114 patients expected by year-end, including 42 in the ovarian cancer cohort [36][43] - NDA submission is anticipated by the end of next year, contingent on follow-up data from the ovarian cancer cohort [42][54] Financial Position - PMV Pharma has approximately $165 million in cash, supporting operations until the end of next year, covering the NDA submission timeline [54][56] Future Development - The company is working on an undisclosed target in lead optimization, with hopes for an IND submission in 2026 [51][52] - There are considerations for combination studies with KRAS inhibitors, although no formal announcements have been made yet [46][47] Key Takeaways - PMV Pharma is addressing a significant unmet medical need in cancer treatment through innovative approaches targeting p53 mutations [58] - The excitement around the interim analysis and ongoing enrollment reflects strong interest from clinical centers [59]
PMV Pharmaceuticals (PMVP) FY Conference Transcript
2025-05-27 16:30
Summary of PMV Pharmaceuticals (PMVP) FY Conference Call Company Overview - **Company**: PMV Pharmaceuticals (PMVP) - **Event**: FY Conference Call on May 27, 2025 Key Points Industry and Company Focus - PMV Pharmaceuticals is focused on oncology, specifically targeting p53 mutations in various solid tumors, including ovarian, lung, breast, and endometrial cancers [4][50]. Clinical Trial Updates - The pivotal Phase 2 trial involves 14 patients with p53 mutations and KRAS wild type across five cohorts: ovarian, lung, breast, endometrial, and others [4]. - As of March, approximately 90% of the targeted 60 sites for patient enrollment were open, with plans to complete enrollment by the end of 2025 [5][6]. - The company expects to enroll 50 patients for an interim analysis, with approximately 40% of these being ovarian cancer patients [10][12]. - The trial is designed to provide data on overall response rates (ORR) and durability of response (DOR) across different cohorts [41][43]. Data and Efficacy Expectations - Previous Phase 1 data indicated a median DOR of seven months across various histologies [14][18]. - The company anticipates that the first responses will be observable at the first or second scan, approximately six to twelve weeks into the trial [20]. - The target ORR for the study is set at 30%, which is considered clinically meaningful for ovarian cancer [58][62]. Regulatory and Commercialization Strategy - PMV Pharmaceuticals is considering filing for regulatory approval (NDA) by the end of 2026, likely focusing on ovarian cancer first due to the higher frequency of p53 mutations in this cohort [52][53]. - The company is engaging with the FDA and has had positive interactions, with no significant changes in the review team noted [74][76]. - There is an ongoing evaluation of commercialization strategies, including potential partnerships, especially for markets outside the US [71][72]. Financial Position - PMV Pharmaceuticals reported a cash position of $166 million, which is expected to sustain operations through 2026, covering the NDA submission process [73]. Additional Insights - The company is actively monitoring patient identification and tolerability issues, noting that p53 mutations are present in all next-generation sequencing (NGS) panels, which aids in patient identification [65]. - PMV Pharmaceuticals is also exploring combination therapies, such as with azacitidine for AML and MDS, with initial patient enrollment underway [81][84]. Future Expectations - An update on the trial data is expected in mid-2025, likely between July and August [8][10]. - The company aims to provide a comprehensive breakdown of data by cohort during the interim analysis [42][43]. This summary encapsulates the critical aspects of PMV Pharmaceuticals' current status, focusing on their clinical trials, regulatory strategies, financial health, and future expectations in the oncology sector.
PMV Pharmaceuticals(PMVP) - 2025 Q1 - Quarterly Report
2025-05-09 12:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39539 PMV PHARMACEUTICALS, INC. (Exact Name of Registrant as Specified in its Charter) WASHINGTON, DC 20549 Delaware 46-3218129 (State or other jurisd ...
PMV Pharmaceuticals(PMVP) - 2025 Q1 - Quarterly Results
2025-05-09 12:00
Financial Performance - PMV Pharmaceuticals ended Q1 2025 with $165.8 million in cash, cash equivalents, and marketable securities, down from $183.3 million as of December 31, 2024[5]. - Net loss for Q1 2025 was $17.5 million, compared to a net loss of $15.3 million for Q1 2024, representing an increase of approximately 14.3%[7]. - PMV Pharma's total assets decreased to $170.6 million as of March 31, 2025, from $191.3 million as of December 31, 2024[13]. - The company reported a net loss per share of $0.34 for Q1 2025, compared to $0.30 for Q1 2024[14]. Expenses - Research and development (R&D) expenses increased to $17.4 million in Q1 2025 from $13.2 million in Q1 2024, reflecting a rise of approximately 32.4%[7]. - General and administrative (G&A) expenses decreased to $4.1 million in Q1 2025 from $5.0 million in Q1 2024, a reduction of approximately 18%[7]. - Total operating expenses for Q1 2025 were $21.6 million, compared to $18.2 million in Q1 2024, marking an increase of approximately 18.5%[14]. Future Plans and Developments - The company plans to provide interim analysis data from the Phase 2 PYNNACLE trial in mid-2025, involving approximately 50 patients, with around 40% in the ovarian cancer cohort[3]. - PMV Pharma's cash runway is expected to extend to the end of 2026 based on current cash reserves[6]. - The FDA granted Fast Track designation to rezatapopt for treating patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation[8].
PMV Pharmaceuticals Reports First Quarter 2025 Financial Results and Corporate Highlights
Globenewswire· 2025-05-09 12:00
Core Insights - PMV Pharmaceuticals reported financial results for Q1 2025, highlighting a net loss of $17.5 million, an increase from $15.3 million in Q1 2024 [4][8][15] - The company has $165.8 million in cash and marketable securities as of March 31, 2025, down from $183.3 million at the end of 2024, providing a cash runway expected to last until the end of 2026 [4][7] - PMV Pharma is advancing its Phase 2 PYNNACLE trial for rezatapopt, with interim analysis data expected in mid-2025, involving approximately 50 patients [2][3][7] Financial Performance - The net cash used in operations for Q1 2025 was $18.3 million, compared to $16.2 million in Q1 2024 [4] - Research and development (R&D) expenses increased to $17.4 million in Q1 2025 from $13.2 million in Q1 2024, primarily due to external expenses related to product candidates [8][15] - General and administrative (G&A) expenses decreased to $4.1 million in Q1 2025 from $5.0 million in Q1 2024, attributed to reduced headcount and operational costs [8][15] Clinical Development - The ongoing Phase 1/2 PYNNACLE trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation, with a focus on safety, tolerability, and pharmacokinetics [6][9] - The primary objective of the Phase 2 portion of the trial is to evaluate the efficacy of rezatapopt at the recommended Phase 2 dose in various cancer cohorts [9] - Rezatapopt has received Fast Track designation from the FDA for treating patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation [5]
Here's Why PMV Pharmaceuticals (PMVP) Looks Ripe for Bottom Fishing
ZACKS· 2025-03-05 15:56
Core Viewpoint - PMV Pharmaceuticals, Inc. (PMVP) has experienced a decline of 9.8% in its stock price over the past week, but the formation of a hammer chart pattern suggests a potential trend reversal as buying interest may be emerging to counteract selling pressure [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottoming out of the stock, with reduced selling pressure and a potential shift in control from bears to bulls [2][4]. - A hammer pattern is characterized by a small candle body and a long lower wick, signaling that despite a downtrend, buying interest has emerged to push the stock price up towards its opening price [3][4]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for PMVP, with a 1.2% increase in the consensus EPS estimate over the last 30 days, indicating analysts' confidence in the company's ability to report better earnings [6][7]. - PMVP holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which historically correlates with outperformance in the market [8].